Trial Outcomes & Findings for Study of GSK3511294 in Healthy Chinese Participants (NCT NCT05140200)
NCT ID: NCT05140200
Last Updated: 2026-05-26
Results Overview
Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Infinity). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
COMPLETED
PHASE1
20 participants
Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183
2026-05-26
Participant Flow
A total of 20 participants were enrolled and randomized in 1:1 ratio in each arm to receive either depemokimab 100 milligrams (mg) or 300 mg.
Participant milestones
| Measure |
Depemokimab 100mg
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Depemokimab 100mg
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study of GSK3511294 in Healthy Chinese Participants
Baseline characteristics by cohort
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.0 Years
STANDARD_DEVIATION 6.23 • n=20 Participants
|
29.4 Years
STANDARD_DEVIATION 6.92 • n=32 Participants
|
29.7 Years
STANDARD_DEVIATION 6.41 • n=64 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
10 Participants
n=32 Participants
|
20 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
10 Participants
n=20 Participants
|
10 Participants
n=32 Participants
|
20 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Infinity). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=9 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) of Depemokimab
|
1685.946 day*micrograms per millilitres
Interval 1540.9579 to 1844.5771
|
5224.107 day*micrograms per millilitres
Interval 4713.29 to 5790.2848
|
PRIMARY outcome
Timeframe: Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for AUC(0-T). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=9 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
AUC From Time 0 (Pre-Dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-T]) of Depemokimab
|
1472.963 day*micrograms per millilitres
Interval 1346.2052 to 1611.6562
|
4604.879 day*micrograms per millilitres
Interval 4133.2379 to 5130.3394
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, and 29Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 4). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 4 post-dose correlates to Day 1 plus 28 days, that is, Day 29.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
AUC From Time 0 (Pre-dose) to Week 4 (AUC[0-Week 4]) of Depemokimab
|
414.467 day*micrograms per millilitres
Interval 367.9103 to 466.9157
|
1357.843 day*micrograms per millilitres
Interval 1207.8494 to 1526.4621
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1); 2 h, 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, and 85Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 12). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, that is, Day 85.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=9 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
AUC From Time 0 (Pre-dose) To Week 12 (AUC[0-Week 12]) Of Depemokimab
|
1027.083 day*micrograms per millilitres
Interval 933.7879 to 1129.699
|
3255.132 day*micrograms per millilitres
Interval 2902.9404 to 3650.0522
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 26). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=9 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
AUC From Time 0 (Pre-dose) To Week 26 [AUC(0-Week 26)] of Depemokimab
|
1472.912 day*micrograms per millilitres
Interval 1346.2052 to 1611.5454
|
4605.772 day*micrograms per millilitres
Interval 4134.0654 to 5131.3018
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for percentage of AUC(0-Infinity) obtained by extrapolation. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=9 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Percentage Of AUC(0-Infinity) Obtained by Extrapolation (%AUCex) of Depemokimab
|
12.381 Percentage of AUCex
Interval 10.7508 to 14.2591
|
11.611 Percentage of AUCex
Interval 9.9214 to 13.5888
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received.
Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Depemokimab
|
16.82 micrograms per milliliters (mcg/mL)
Interval 14.782 to 19.144
|
55.04 micrograms per milliliters (mcg/mL)
Interval 48.183 to 62.867
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received.
Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters were calculated by standard non compartmental analysis. Tmax was determined directly from the plasma concentration-time data. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Time of Occurrence of Cmax (Tmax) Of Depemokimab
|
13.960 Days
Interval 3.98 to 27.95
|
13.980 Days
Interval 4.0 to 27.98
|
PRIMARY outcome
Timeframe: Pre-dose (day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=9 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Time To Last Quantifiable Concentration (Tlast) of Depemokimab
|
181.980 Days
Interval 181.97 to 182.19
|
181.980 Days
Interval 180.96 to 182.06
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for Apparent Clearance. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=9 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Apparent Clearance (CL/F) of Depemokimab
|
0.0593 Liters per day
Interval 0.0542 to 0.0649
|
0.0574 Liters per day
Interval 0.0518 to 0.0636
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for apparent volume of distribution. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=9 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Depemokimab
|
5.033 Litres
Interval 4.5599 to 5.5554
|
4.827 Litres
Interval 4.2489 to 5.483
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for Terminal elimination rate constant. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=9 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Terminal Elimination Rate Constant (Lambda Z) of Depemokimab
|
0.0118 Per Day
Interval 0.0111 to 0.0125
|
0.0119 Per Day
Interval 0.0112 to 0.0127
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183Population: The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for Terminal phase half-life. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=9 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Terminal Phase Half-Life (T1/2) of Depemokimab
|
58.827 Days
Interval 55.5367 to 62.3132
|
58.246 Days
Interval 54.7008 to 62.0215
|
SECONDARY outcome
Timeframe: From the start of the study intervention (Day 1) up to Day 211 (End of follow-up)Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or is considered or defined as an important medical event.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Number of Participants With Adverse Events (AE) And Serious Adverse Events (SAEs)
Adverse Events
|
10 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events (AE) And Serious Adverse Events (SAEs)
Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential that is, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Basophils, Day 2
|
-0.000 10^9 cells/L
Standard Deviation 0.0125
|
-0.007 10^9 cells/L
Standard Deviation 0.0082
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Basophils, Day 3
|
-0.006 10^9 cells/L
Standard Deviation 0.0126
|
-0.002 10^9 cells/L
Standard Deviation 0.0123
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Basophils, Day 5
|
-0.005 10^9 cells/L
Standard Deviation 0.0127
|
-0.002 10^9 cells/L
Standard Deviation 0.0132
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Basophils, Week 1
|
-0.007 10^9 cells/L
Standard Deviation 0.0082
|
-0.009 10^9 cells/L
Standard Deviation 0.0074
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Basophils, Week 2
|
-0.006 10^9 cells/L
Standard Deviation 0.0107
|
-0.009 10^9 cells/L
Standard Deviation 0.0099
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Basophils, Week 4
|
-0.010 10^9 cells/L
Standard Deviation 0.0156
|
-0.009 10^9 cells/L
Standard Deviation 0.0129
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Basophils, Week 8
|
-0.001 10^9 cells/L
Standard Deviation 0.0120
|
-0.011 10^9 cells/L
Standard Deviation 0.0129
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Basophils, Week 12
|
-0.010 10^9 cells/L
Standard Deviation 0.0105
|
-0.014 10^9 cells/L
Standard Deviation 0.0133
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Basophils, Week 18
|
-0.009 10^9 cells/L
Standard Deviation 0.0099
|
-0.009 10^9 cells/L
Standard Deviation 0.0105
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Basophils, Week 24
|
-0.005 10^9 cells/L
Standard Deviation 0.0135
|
-0.016 10^9 cells/L
Standard Deviation 0.0174
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Basophils, Week 26
|
-0.004 10^9 cells/L
Standard Deviation 0.0135
|
-0.007 10^9 cells/L
Standard Deviation 0.0100
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Eosinophils, Day 2
|
-0.090 10^9 cells/L
Standard Deviation 0.0720
|
-0.046 10^9 cells/L
Standard Deviation 0.0401
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Eosinophils, Day 3
|
-0.101 10^9 cells/L
Standard Deviation 0.0824
|
-0.049 10^9 cells/L
Standard Deviation 0.0463
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Eosinophils, Day 5
|
-0.114 10^9 cells/L
Standard Deviation 0.0875
|
-0.059 10^9 cells/L
Standard Deviation 0.0404
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Eosinophils, Week 1
|
-0.117 10^9 cells/L
Standard Deviation 0.0858
|
-0.060 10^9 cells/L
Standard Deviation 0.0429
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Eosinophils, Week 2
|
-0.122 10^9 cells/L
Standard Deviation 0.0889
|
-0.055 10^9 cells/L
Standard Deviation 0.0414
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Eosinophils, Week 4
|
-0.128 10^9 cells/L
Standard Deviation 0.0986
|
-0.063 10^9 cells/L
Standard Deviation 0.0499
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Eosinophils, Week 8
|
-0.129 10^9 cells/L
Standard Deviation 0.1092
|
-0.068 10^9 cells/L
Standard Deviation 0.0432
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Eosinophils, Week 12
|
-0.132 10^9 cells/L
Standard Deviation 0.1017
|
-0.068 10^9 cells/L
Standard Deviation 0.0435
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Eosinophils, Week 18
|
-0.123 10^9 cells/L
Standard Deviation 0.0943
|
-0.064 10^9 cells/L
Standard Deviation 0.0522
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Eosinophils, Week 24
|
-0.126 10^9 cells/L
Standard Deviation 0.0982
|
-0.077 10^9 cells/L
Standard Deviation 0.0480
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Eosinophils, Week 26
|
-0.122 10^9 cells/L
Standard Deviation 0.0919
|
-0.069 10^9 cells/L
Standard Deviation 0.0506
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Lymphocytes, Day 2
|
-0.23 10^9 cells/L
Standard Deviation 0.337
|
-0.11 10^9 cells/L
Standard Deviation 0.088
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Lymphocytes, Day 3
|
-0.32 10^9 cells/L
Standard Deviation 0.385
|
-0.16 10^9 cells/L
Standard Deviation 0.276
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Lymphocytes, Day 5
|
-0.14 10^9 cells/L
Standard Deviation 0.337
|
-0.18 10^9 cells/L
Standard Deviation 0.204
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Lymphocytes, Week 1
|
-0.20 10^9 cells/L
Standard Deviation 0.327
|
-0.23 10^9 cells/L
Standard Deviation 0.177
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Lymphocytes, Week 2
|
-0.03 10^9 cells/L
Standard Deviation 0.440
|
0.01 10^9 cells/L
Standard Deviation 0.191
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Lymphocytes, Week 4
|
0.12 10^9 cells/L
Standard Deviation 0.505
|
-0.09 10^9 cells/L
Standard Deviation 0.260
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Lymphocytes, Week 8
|
0.16 10^9 cells/L
Standard Deviation 0.320
|
0.03 10^9 cells/L
Standard Deviation 0.353
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Lymphocytes, Week 12
|
-0.21 10^9 cells/L
Standard Deviation 0.331
|
-0.04 10^9 cells/L
Standard Deviation 0.381
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Lymphocytes, Week 18
|
-0.11 10^9 cells/L
Standard Deviation 0.384
|
-0.12 10^9 cells/L
Standard Deviation 0.291
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Lymphocytes, Week 24
|
-0.20 10^9 cells/L
Standard Deviation 0.422
|
-0.20 10^9 cells/L
Standard Deviation 0.418
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Lymphocytes, Week 26
|
-0.21 10^9 cells/L
Standard Deviation 0.477
|
-0.18 10^9 cells/L
Standard Deviation 0.427
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Monocytes, Day 2
|
-0.05 10^9 cells/L
Standard Deviation 0.085
|
0.01 10^9 cells/L
Standard Deviation 0.057
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Monocytes, Day 3
|
-0.06 10^9 cells/L
Standard Deviation 0.084
|
0.04 10^9 cells/L
Standard Deviation 0.052
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Monocytes, Day 5
|
0.01 10^9 cells/L
Standard Deviation 0.088
|
0.05 10^9 cells/L
Standard Deviation 0.053
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Monocytes, Week 1
|
-0.05 10^9 cells/L
Standard Deviation 0.097
|
0.04 10^9 cells/L
Standard Deviation 0.117
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Monocytes, Week 2
|
-0.04 10^9 cells/L
Standard Deviation 0.126
|
0.01 10^9 cells/L
Standard Deviation 0.074
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Monocytes, Week 4
|
0.00 10^9 cells/L
Standard Deviation 0.115
|
0.01 10^9 cells/L
Standard Deviation 0.057
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Monocytes, Week 8
|
0.04 10^9 cells/L
Standard Deviation 0.052
|
0.07 10^9 cells/L
Standard Deviation 0.125
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Monocytes, Week 12
|
-0.06 10^9 cells/L
Standard Deviation 0.107
|
0.09 10^9 cells/L
Standard Deviation 0.060
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Monocytes, Week 18
|
-0.02 10^9 cells/L
Standard Deviation 0.092
|
0.08 10^9 cells/L
Standard Deviation 0.109
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Monocytes, Week 24
|
-0.02 10^9 cells/L
Standard Deviation 0.079
|
0.04 10^9 cells/L
Standard Deviation 0.053
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Monocytes, Week 26
|
-0.03 10^9 cells/L
Standard Deviation 0.116
|
0.07 10^9 cells/L
Standard Deviation 0.100
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Neutrophils, Day 2
|
0.12 10^9 cells/L
Standard Deviation 1.497
|
0.05 10^9 cells/L
Standard Deviation 0.693
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Neutrophils, Day 3
|
-0.45 10^9 cells/L
Standard Deviation 0.992
|
0.08 10^9 cells/L
Standard Deviation 0.960
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Neutrophils, Day 5
|
-0.15 10^9 cells/L
Standard Deviation 0.941
|
0.08 10^9 cells/L
Standard Deviation 1.090
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Neutrophils, Week 1
|
-0.52 10^9 cells/L
Standard Deviation 1.052
|
-0.21 10^9 cells/L
Standard Deviation 1.179
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Neutrophils, Week 2
|
0.19 10^9 cells/L
Standard Deviation 1.819
|
-0.12 10^9 cells/L
Standard Deviation 0.878
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Neutrophils, Week 4
|
-0.42 10^9 cells/L
Standard Deviation 1.096
|
-0.01 10^9 cells/L
Standard Deviation 0.679
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Neutrophils, Week 8
|
-0.16 10^9 cells/L
Standard Deviation 1.178
|
-0.09 10^9 cells/L
Standard Deviation 1.175
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Neutrophils, Week 12
|
-0.48 10^9 cells/L
Standard Deviation 1.212
|
0.19 10^9 cells/L
Standard Deviation 0.483
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Neutrophils, Week 18
|
-0.39 10^9 cells/L
Standard Deviation 1.112
|
0.79 10^9 cells/L
Standard Deviation 0.770
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Neutrophils, Week 24
|
-0.06 10^9 cells/L
Standard Deviation 0.999
|
0.33 10^9 cells/L
Standard Deviation 0.819
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Neutrophils, Week 26
|
-0.13 10^9 cells/L
Standard Deviation 1.591
|
0.77 10^9 cells/L
Standard Deviation 1.052
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Platelets, Day 2
|
-10.8 10^9 cells/L
Standard Deviation 12.56
|
5.7 10^9 cells/L
Standard Deviation 12.81
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Platelets, Day 3
|
-1.9 10^9 cells/L
Standard Deviation 14.16
|
-0.3 10^9 cells/L
Standard Deviation 13.75
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Platelets, Day 5
|
-6.1 10^9 cells/L
Standard Deviation 10.18
|
1.7 10^9 cells/L
Standard Deviation 15.90
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Platelets, Week 1
|
-21.8 10^9 cells/L
Standard Deviation 14.17
|
-5.5 10^9 cells/L
Standard Deviation 11.71
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Platelets, Week 2
|
-9.4 10^9 cells/L
Standard Deviation 19.97
|
4.5 10^9 cells/L
Standard Deviation 15.50
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Platelets, Week 4
|
-10.4 10^9 cells/L
Standard Deviation 15.77
|
7.5 10^9 cells/L
Standard Deviation 19.55
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Platelets, Week 8
|
-13.6 10^9 cells/L
Standard Deviation 23.77
|
3.4 10^9 cells/L
Standard Deviation 23.24
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Platelets, Week 12
|
-15.6 10^9 cells/L
Standard Deviation 23.68
|
4.3 10^9 cells/L
Standard Deviation 47.56
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Platelets, Week 18
|
-11.2 10^9 cells/L
Standard Deviation 20.43
|
-1.7 10^9 cells/L
Standard Deviation 29.48
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Platelets, Week 24
|
-22.7 10^9 cells/L
Standard Deviation 19.45
|
22.6 10^9 cells/L
Standard Deviation 18.77
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Platelets, Week 26
|
-18.9 10^9 cells/L
Standard Deviation 22.26
|
-2.7 10^9 cells/L
Standard Deviation 25.31
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Leukocytes, Day 2
|
-0.240 10^9 cells/L
Standard Deviation 1.5414
|
-0.070 10^9 cells/L
Standard Deviation 0.7424
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Leukocytes, Day 3
|
-0.900 10^9 cells/L
Standard Deviation 0.9752
|
-0.100 10^9 cells/L
Standard Deviation 0.9404
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Leukocytes, Day 5
|
-0.390 10^9 cells/L
Standard Deviation 0.8465
|
-0.080 10^9 cells/L
Standard Deviation 1.1203
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Leukocytes, Week 1
|
-0.880 10^9 cells/L
Standard Deviation 1.2506
|
-0.480 10^9 cells/L
Standard Deviation 1.1203
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Leukocytes, Week 2
|
-0.020 10^9 cells/L
Standard Deviation 1.7061
|
-0.140 10^9 cells/L
Standard Deviation 1.0035
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Leukocytes, Week 4
|
-0.400 10^9 cells/L
Standard Deviation 1.4314
|
-0.180 10^9 cells/L
Standard Deviation 0.7899
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Leukocytes, Week 8
|
-0.090 10^9 cells/L
Standard Deviation 1.0546
|
-0.080 10^9 cells/L
Standard Deviation 1.4382
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Leukocytes, Week 12
|
-0.870 10^9 cells/L
Standard Deviation 1.3073
|
0.111 10^9 cells/L
Standard Deviation 0.5883
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Leukocytes, Week 18
|
-0.640 10^9 cells/L
Standard Deviation 1.1197
|
0.667 10^9 cells/L
Standard Deviation 0.7778
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Leukocytes, Week 24
|
-0.400 10^9 cells/L
Standard Deviation 1.1025
|
0.034 10^9 cells/L
Standard Deviation 0.8914
|
|
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes
Leukocytes, Week 26
|
-0.470 10^9 cells/L
Standard Deviation 1.4476
|
0.048 10^9 cells/L
Standard Deviation 1.6991
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for the assessment of change from baseline in hematology parameters including Hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 4
|
-2.5 Gram per Liter
Standard Deviation 7.88
|
-5.8 Gram per Liter
Standard Deviation 7.19
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Day 2
|
-3.5 Gram per Liter
Standard Deviation 7.68
|
-2.1 Gram per Liter
Standard Deviation 2.81
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Day 3
|
-1.0 Gram per Liter
Standard Deviation 6.25
|
-5.2 Gram per Liter
Standard Deviation 4.85
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Day 5
|
-3.6 Gram per Liter
Standard Deviation 10.86
|
-6.2 Gram per Liter
Standard Deviation 5.63
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 1
|
-6.4 Gram per Liter
Standard Deviation 10.94
|
-7.0 Gram per Liter
Standard Deviation 5.64
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 2
|
-2.5 Gram per Liter
Standard Deviation 7.88
|
-7.5 Gram per Liter
Standard Deviation 6.35
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 8
|
-0.7 Gram per Liter
Standard Deviation 9.27
|
-8.9 Gram per Liter
Standard Deviation 4.79
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 12
|
-2.2 Gram per Liter
Standard Deviation 8.30
|
-8.9 Gram per Liter
Standard Deviation 8.77
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 18
|
-2.3 Gram per Liter
Standard Deviation 8.83
|
-4.0 Gram per Liter
Standard Deviation 6.12
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 24
|
-4.3 Gram per Liter
Standard Deviation 8.59
|
-5.4 Gram per Liter
Standard Deviation 5.66
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 26
|
-4.3 Gram per Liter
Standard Deviation 6.63
|
-2.6 Gram per Liter
Standard Deviation 7.49
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for the assessment of change from baseline in hematology parameters including Hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit
Day 2
|
-0.0112 Liter/liter
Standard Deviation 0.0148
|
-0.0191 Liter/liter
Standard Deviation 0.0105
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Day 3
|
-0.0077 Liter/liter
Standard Deviation 0.0195
|
-0.0231 Liter/liter
Standard Deviation 0.0197
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Day 5
|
-0.0136 Liter/liter
Standard Deviation 0.0311
|
-0.0170 Liter/liter
Standard Deviation 0.0180
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 1
|
-0.0189 Liter/liter
Standard Deviation 0.0327
|
-0.0194 Liter/liter
Standard Deviation 0.0170
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 2
|
-0.0075 Liter/liter
Standard Deviation 0.0202
|
-0.0210 Liter/liter
Standard Deviation 0.0173
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 4
|
-0.0092 Liter/liter
Standard Deviation 0.0202
|
-0.0174 Liter/liter
Standard Deviation 0.0181
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 8
|
0.0029 Liter/liter
Standard Deviation 0.0248
|
-0.0210 Liter/liter
Standard Deviation 0.0163
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 12
|
-0.0032 Liter/liter
Standard Deviation 0.0232
|
-0.0241 Liter/liter
Standard Deviation 0.0221
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 18
|
-0.0093 Liter/liter
Standard Deviation 0.0234
|
-0.0084 Liter/liter
Standard Deviation 0.0161
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 24
|
0.0003 Liter/liter
Standard Deviation 0.0252
|
-0.0149 Liter/liter
Standard Deviation 0.0099
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 26
|
-0.0021 Liter/liter
Standard Deviation 0.0164
|
-0.0158 Liter/liter
Standard Deviation 0.0169
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for the assessment of change from baseline in hematology parameters including mean corpuscular volume. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Day 2
|
-0.75 Femtoliters
Standard Deviation 0.746
|
-0.23 Femtoliters
Standard Deviation 0.403
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Day 3
|
1.41 Femtoliters
Standard Deviation 1.457
|
0.60 Femtoliters
Standard Deviation 0.400
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Day 5
|
-0.22 Femtoliters
Standard Deviation 0.773
|
0.26 Femtoliters
Standard Deviation 0.493
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Week 1
|
-0.46 Femtoliters
Standard Deviation 0.769
|
0.09 Femtoliters
Standard Deviation 0.318
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Week 2
|
-0.07 Femtoliters
Standard Deviation 0.607
|
0.17 Femtoliters
Standard Deviation 0.760
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Week 4
|
0.07 Femtoliters
Standard Deviation 1.002
|
0.53 Femtoliters
Standard Deviation 0.898
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Week 8
|
0.33 Femtoliters
Standard Deviation 1.124
|
0.77 Femtoliters
Standard Deviation 1.087
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Week 12
|
-0.27 Femtoliters
Standard Deviation 1.427
|
-0.10 Femtoliters
Standard Deviation 2.062
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Week 18
|
-0.13 Femtoliters
Standard Deviation 1.425
|
0.27 Femtoliters
Standard Deviation 1.885
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Week 24
|
0.50 Femtoliters
Standard Deviation 0.627
|
0.56 Femtoliters
Standard Deviation 1.544
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Week 26
|
0.37 Femtoliters
Standard Deviation 0.974
|
-0.96 Femtoliters
Standard Deviation 1.726
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for the assessment of change from baseline in hematology parameters including mean Corpuscular Hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Day 2
|
-0.01 Picograms (pg)
Standard Deviation 0.166
|
0.81 Picograms (pg)
Standard Deviation 0.360
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Day 3
|
0.86 Picograms (pg)
Standard Deviation 0.438
|
0.72 Picograms (pg)
Standard Deviation 0.592
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Day 5
|
0.20 Picograms (pg)
Standard Deviation 0.462
|
-0.04 Picograms (pg)
Standard Deviation 0.267
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Week 1
|
-0.13 Picograms (pg)
Standard Deviation 0.206
|
-0.04 Picograms (pg)
Standard Deviation 0.313
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Week 2
|
-0.16 Picograms (pg)
Standard Deviation 0.255
|
0.04 Picograms (pg)
Standard Deviation 0.558
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Week 4
|
0.13 Picograms (pg)
Standard Deviation 0.432
|
0.18 Picograms (pg)
Standard Deviation 0.416
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Week 8
|
-0.18 Picograms (pg)
Standard Deviation 0.266
|
-0.09 Picograms (pg)
Standard Deviation 0.702
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Week 12
|
-0.33 Picograms (pg)
Standard Deviation 0.374
|
-0.21 Picograms (pg)
Standard Deviation 0.395
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Week 18
|
0.17 Picograms (pg)
Standard Deviation 0.241
|
-0.11 Picograms (pg)
Standard Deviation 0.504
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Week 24
|
-0.69 Picograms (pg)
Standard Deviation 0.273
|
0.07 Picograms (pg)
Standard Deviation 0.579
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Week 26
|
-0.55 Picograms (pg)
Standard Deviation 0.350
|
0.24 Picograms (pg)
Standard Deviation 0.754
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected for the assessment of change from baseline in hematology parameters including Reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Reticulocytes
Day 5
|
0.083 Percentage
Standard Deviation 0.2090
|
0.046 Percentage
Standard Deviation 0.1254
|
|
Change From Baseline in Hematology Parameter: Reticulocytes
Day 2
|
-0.052 Percentage
Standard Deviation 0.1471
|
0.085 Percentage
Standard Deviation 0.0669
|
|
Change From Baseline in Hematology Parameter: Reticulocytes
Day 3
|
0.601 Percentage
Standard Deviation 0.6413
|
0.162 Percentage
Standard Deviation 0.0933
|
|
Change From Baseline in Hematology Parameter: Reticulocytes
Week 1
|
0.004 Percentage
Standard Deviation 0.1593
|
0.071 Percentage
Standard Deviation 0.1091
|
|
Change From Baseline in Hematology Parameter: Reticulocytes
Week 2
|
-0.047 Percentage
Standard Deviation 0.1636
|
0.118 Percentage
Standard Deviation 0.1686
|
|
Change From Baseline in Hematology Parameter: Reticulocytes
Week 4
|
0.123 Percentage
Standard Deviation 0.4205
|
0.134 Percentage
Standard Deviation 0.1686
|
|
Change From Baseline in Hematology Parameter: Reticulocytes
Week 8
|
0.107 Percentage
Standard Deviation 0.3578
|
0.682 Percentage
Standard Deviation 0.4978
|
|
Change From Baseline in Hematology Parameter: Reticulocytes
Week 12
|
0.137 Percentage
Standard Deviation 0.1762
|
0.656 Percentage
Standard Deviation 0.2779
|
|
Change From Baseline in Hematology Parameter: Reticulocytes
Week 18
|
0.037 Percentage
Standard Deviation 0.2155
|
0.312 Percentage
Standard Deviation 0.1923
|
|
Change From Baseline in Hematology Parameter: Reticulocytes
Week 24
|
0.126 Percentage
Standard Deviation 0.1675
|
0.624 Percentage
Standard Deviation 0.3206
|
|
Change From Baseline in Hematology Parameter: Reticulocytes
Week 26
|
0.099 Percentage
Standard Deviation 0.1200
|
0.318 Percentage
Standard Deviation 0.2828
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Change from baseline in hematology parameter including Erythrocytes. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline In Hematology Parameter: Erythrocytes
Day 2
|
-0.083 10^12 cells per liter
Standard Deviation 0.1904
|
-0.197 10^12 cells per liter
Standard Deviation 0.1225
|
|
Change From Baseline In Hematology Parameter: Erythrocytes
Day 3
|
-0.160 10^12 cells per liter
Standard Deviation 0.2322
|
-0.289 10^12 cells per liter
Standard Deviation 0.2102
|
|
Change From Baseline In Hematology Parameter: Erythrocytes
Day 5
|
-0.138 10^12 cells per liter
Standard Deviation 0.3643
|
-0.205 10^12 cells per liter
Standard Deviation 0.2059
|
|
Change From Baseline In Hematology Parameter: Erythrocytes
Week 2
|
-0.080 10^12 cells per liter
Standard Deviation 0.2262
|
-0.242 10^12 cells per liter
Standard Deviation 0.2060
|
|
Change From Baseline In Hematology Parameter: Erythrocytes
Week 4
|
-0.104 10^12 cells per liter
Standard Deviation 0.1979
|
-0.225 10^12 cells per liter
Standard Deviation 0.2154
|
|
Change From Baseline In Hematology Parameter: Erythrocytes
Week 8
|
0.011 10^12 cells per liter
Standard Deviation 0.2986
|
-0.271 10^12 cells per liter
Standard Deviation 0.1777
|
|
Change From Baseline In Hematology Parameter: Erythrocytes
Week 12
|
-0.019 10^12 cells per liter
Standard Deviation 0.2729
|
-0.258 10^12 cells per liter
Standard Deviation 0.2909
|
|
Change From Baseline In Hematology Parameter: Erythrocytes
Week 1
|
-0.182 10^12 cells per liter
Standard Deviation 0.3466
|
-0.221 10^12 cells per liter
Standard Deviation 0.1875
|
|
Change From Baseline In Hematology Parameter: Erythrocytes
Week 18
|
-0.097 10^12 cells per liter
Standard Deviation 0.2589
|
-0.107 10^12 cells per liter
Standard Deviation 0.2389
|
|
Change From Baseline In Hematology Parameter: Erythrocytes
Week 24
|
-0.026 10^12 cells per liter
Standard Deviation 0.2611
|
-0.189 10^12 cells per liter
Standard Deviation 0.1619
|
|
Change From Baseline In Hematology Parameter: Erythrocytes
Week 26
|
-0.043 10^12 cells per liter
Standard Deviation 0.1945
|
-0.123 10^12 cells per liter
Standard Deviation 0.2421
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose on Day -1), Week 1, 4, 8, 12, 24 and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples was collected for the assessment of clinical chemistry parameters including Sodium, potassium, calcium, glucose, and urea. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Urea, Week 26
|
0.179 Millimoles per liter
Standard Deviation 0.9985
|
0.067 Millimoles per liter
Standard Deviation 0.9667
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Glucose, Week 1
|
0.151 Millimoles per liter
Standard Deviation 0.2426
|
-0.138 Millimoles per liter
Standard Deviation 0.3356
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Glucose, Week 4
|
0.089 Millimoles per liter
Standard Deviation 0.2552
|
0.327 Millimoles per liter
Standard Deviation 1.2921
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Glucose, Week 8
|
0.030 Millimoles per liter
Standard Deviation 0.3929
|
-0.026 Millimoles per liter
Standard Deviation 0.3219
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Glucose, Week 12
|
0.151 Millimoles per liter
Standard Deviation 0.2487
|
-0.132 Millimoles per liter
Standard Deviation 0.3391
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Glucose, Week 24
|
-0.169 Millimoles per liter
Standard Deviation 0.4133
|
0.468 Millimoles per liter
Standard Deviation 0.3080
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Urea, Week 24
|
0.215 Millimoles per liter
Standard Deviation 0.7788
|
0.318 Millimoles per liter
Standard Deviation 0.5073
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Glucose, Week 26
|
-0.271 Millimoles per liter
Standard Deviation 0.3511
|
0.350 Millimoles per liter
Standard Deviation 0.6094
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Sodium, Week 1
|
1.1 Millimoles per liter
Standard Deviation 1.10
|
0.9 Millimoles per liter
Standard Deviation 1.73
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Sodium, Week 4
|
-0.3 Millimoles per liter
Standard Deviation 1.57
|
0.1 Millimoles per liter
Standard Deviation 1.91
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Sodium, Week 8
|
0.3 Millimoles per liter
Standard Deviation 1.06
|
0.9 Millimoles per liter
Standard Deviation 2.23
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Sodium, Week 12
|
-1.1 Millimoles per liter
Standard Deviation 1.79
|
-0.1 Millimoles per liter
Standard Deviation 2.09
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Sodium, Week 24
|
-1.7 Millimoles per liter
Standard Deviation 2.50
|
0.7 Millimoles per liter
Standard Deviation 2.29
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Sodium, Week 26
|
-0.9 Millimoles per liter
Standard Deviation 1.60
|
0.1 Millimoles per liter
Standard Deviation 1.83
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Potassium, Week 1
|
0.045 Millimoles per liter
Standard Deviation 0.1932
|
-0.106 Millimoles per liter
Standard Deviation 0.1246
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Potassium, Week 4
|
-0.031 Millimoles per liter
Standard Deviation 0.2265
|
-0.189 Millimoles per liter
Standard Deviation 0.2365
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Potassium, Week 8
|
-0.028 Millimoles per liter
Standard Deviation 0.3262
|
-0.242 Millimoles per liter
Standard Deviation 0.1728
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Potassium, Week 12
|
-0.042 Millimoles per liter
Standard Deviation 0.2665
|
-0.427 Millimoles per liter
Standard Deviation 0.2293
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Potassium, Week 24
|
-0.131 Millimoles per liter
Standard Deviation 0.2347
|
-0.098 Millimoles per liter
Standard Deviation 0.1161
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Potassium, Week 26
|
-0.106 Millimoles per liter
Standard Deviation 0.2360
|
-0.252 Millimoles per liter
Standard Deviation 0.1716
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Calcium, Week 1
|
0.052 Millimoles per liter
Standard Deviation 0.1105
|
-0.037 Millimoles per liter
Standard Deviation 0.0295
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Calcium, Week 4
|
0.010 Millimoles per liter
Standard Deviation 0.1159
|
-0.002 Millimoles per liter
Standard Deviation 0.0432
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Calcium, Week 8
|
0.065 Millimoles per liter
Standard Deviation 0.1084
|
-0.018 Millimoles per liter
Standard Deviation 0.1054
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Calcium, Week 12
|
0.039 Millimoles per liter
Standard Deviation 0.1034
|
-0.017 Millimoles per liter
Standard Deviation 0.0901
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Calcium, Week 24
|
0.073 Millimoles per liter
Standard Deviation 0.1335
|
0.021 Millimoles per liter
Standard Deviation 0.0326
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Calcium, Week 26
|
0.018 Millimoles per liter
Standard Deviation 0.1036
|
-0.111 Millimoles per liter
Standard Deviation 0.0824
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Urea, Week 1
|
0.447 Millimoles per liter
Standard Deviation 1.1678
|
0.084 Millimoles per liter
Standard Deviation 0.8962
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Urea, Week 4
|
0.083 Millimoles per liter
Standard Deviation 0.6965
|
0.679 Millimoles per liter
Standard Deviation 0.9138
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Urea, Week 8
|
0.251 Millimoles per liter
Standard Deviation 0.8523
|
0.164 Millimoles per liter
Standard Deviation 1.0094
|
|
Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea
Urea, Week 12
|
0.069 Millimoles per liter
Standard Deviation 0.6141
|
0.102 Millimoles per liter
Standard Deviation 0.6358
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples was collected for the assessment of clinical chemistry parameters including direct bilirubin, bilirubin, and creatinine\[MB10.1\]. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Direct Bilirubin, Week 1
|
-0.62 Micromoles per Liter
Standard Deviation 1.262
|
0.17 Micromoles per Liter
Standard Deviation 0.996
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Direct Bilirubin, Week 4
|
-0.30 Micromoles per Liter
Standard Deviation 1.572
|
-0.28 Micromoles per Liter
Standard Deviation 1.778
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Direct Bilirubin, Week 8
|
-0.77 Micromoles per Liter
Standard Deviation 1.451
|
0.74 Micromoles per Liter
Standard Deviation 1.059
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Direct Bilirubin, Week 12
|
0.12 Micromoles per Liter
Standard Deviation 2.404
|
0.79 Micromoles per Liter
Standard Deviation 0.862
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Direct Bilirubin, Week 24
|
-0.12 Micromoles per Liter
Standard Deviation 1.497
|
0.27 Micromoles per Liter
Standard Deviation 1.228
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Direct Bilirubin, Week 26
|
0.22 Micromoles per Liter
Standard Deviation 2.140
|
0.61 Micromoles per Liter
Standard Deviation 2.781
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Bilirubin, Week 1
|
-2.10 Micromoles per Liter
Standard Deviation 3.544
|
0.14 Micromoles per Liter
Standard Deviation 3.622
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Bilirubin, Week 4
|
-1.19 Micromoles per Liter
Standard Deviation 5.297
|
-1.57 Micromoles per Liter
Standard Deviation 6.771
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Bilirubin, Week 8
|
-1.27 Micromoles per Liter
Standard Deviation 4.252
|
0.99 Micromoles per Liter
Standard Deviation 2.915
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Bilirubin, Week 12
|
1.03 Micromoles per Liter
Standard Deviation 6.365
|
0.48 Micromoles per Liter
Standard Deviation 2.618
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Bilirubin, Week 24
|
-0.38 Micromoles per Liter
Standard Deviation 4.361
|
-0.32 Micromoles per Liter
Standard Deviation 4.346
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Bilirubin, Week 26
|
1.06 Micromoles per Liter
Standard Deviation 5.719
|
-1.14 Micromoles per Liter
Standard Deviation 8.219
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Creatinine, Week 1
|
-0.6 Micromoles per Liter
Standard Deviation 7.46
|
-4.1 Micromoles per Liter
Standard Deviation 4.09
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Creatinine, Week 4
|
0.7 Micromoles per Liter
Standard Deviation 4.88
|
1.6 Micromoles per Liter
Standard Deviation 6.19
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Creatinine, Week 8
|
2.5 Micromoles per Liter
Standard Deviation 9.91
|
2.5 Micromoles per Liter
Standard Deviation 6.72
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Creatinine, Week 12
|
0.1 Micromoles per Liter
Standard Deviation 7.49
|
-2.1 Micromoles per Liter
Standard Deviation 5.71
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Creatinine, Week 24
|
0.1 Micromoles per Liter
Standard Deviation 5.63
|
-1.0 Micromoles per Liter
Standard Deviation 7.19
|
|
Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine
Creatinine, Week 26
|
-1.5 Micromoles per Liter
Standard Deviation 7.35
|
-0.3 Micromoles per Liter
Standard Deviation 6.75
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples was collected for the assessment of clinical chemistry parameters including AST, ALT, ALP, and GGT. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALP, Week 4
|
0.7 Units Per Liter
Standard Deviation 7.17
|
1.3 Units Per Liter
Standard Deviation 6.75
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALP, Week 1
|
-1.7 Units Per Liter
Standard Deviation 4.92
|
-1.9 Units Per Liter
Standard Deviation 6.94
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALP, Week 8
|
0.9 Units Per Liter
Standard Deviation 7.23
|
-2.7 Units Per Liter
Standard Deviation 4.06
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALP, Week 12
|
1.5 Units Per Liter
Standard Deviation 6.88
|
-3.4 Units Per Liter
Standard Deviation 6.44
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALP, Week 24
|
3.9 Units Per Liter
Standard Deviation 9.34
|
-0.9 Units Per Liter
Standard Deviation 9.10
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALP, Week 26
|
1.2 Units Per Liter
Standard Deviation 6.99
|
1.6 Units Per Liter
Standard Deviation 7.91
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALT, Week 1
|
1.0 Units Per Liter
Standard Deviation 6.70
|
-3.4 Units Per Liter
Standard Deviation 3.89
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALT, Week 4
|
-0.7 Units Per Liter
Standard Deviation 4.32
|
-2.8 Units Per Liter
Standard Deviation 8.00
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALT, Week 8
|
1.9 Units Per Liter
Standard Deviation 6.67
|
-0.8 Units Per Liter
Standard Deviation 8.80
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALT, Week 12
|
3.6 Units Per Liter
Standard Deviation 6.70
|
-1.9 Units Per Liter
Standard Deviation 9.97
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALT, Week 24
|
3.3 Units Per Liter
Standard Deviation 9.24
|
-3.1 Units Per Liter
Standard Deviation 8.98
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
ALT, Week 26
|
0.6 Units Per Liter
Standard Deviation 6.59
|
0.9 Units Per Liter
Standard Deviation 18.18
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
AST, Week 1
|
1.5 Units Per Liter
Standard Deviation 2.01
|
-0.6 Units Per Liter
Standard Deviation 5.13
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
AST, Week 4
|
1.6 Units Per Liter
Standard Deviation 3.72
|
0.6 Units Per Liter
Standard Deviation 6.69
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
AST, Week 8
|
1.3 Units Per Liter
Standard Deviation 3.56
|
-0.2 Units Per Liter
Standard Deviation 2.86
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
AST, Week 12
|
3.1 Units Per Liter
Standard Deviation 4.04
|
2.1 Units Per Liter
Standard Deviation 4.88
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
AST, Week 24
|
2.9 Units Per Liter
Standard Deviation 4.15
|
0.2 Units Per Liter
Standard Deviation 2.91
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
AST, Week 26
|
1.1 Units Per Liter
Standard Deviation 3.48
|
4.8 Units Per Liter
Standard Deviation 7.64
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
GGT, Week 1
|
0.8 Units Per Liter
Standard Deviation 2.94
|
-0.5 Units Per Liter
Standard Deviation 2.99
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
GGT, Week 4
|
0.1 Units Per Liter
Standard Deviation 2.23
|
-0.2 Units Per Liter
Standard Deviation 4.24
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
GGT, Week 8
|
5.6 Units Per Liter
Standard Deviation 5.97
|
4.1 Units Per Liter
Standard Deviation 14.50
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
GGT, Week 12
|
4.2 Units Per Liter
Standard Deviation 3.19
|
-0.4 Units Per Liter
Standard Deviation 5.70
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
GGT, Week 24
|
5.1 Units Per Liter
Standard Deviation 7.82
|
-0.1 Units Per Liter
Standard Deviation 6.11
|
|
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT)
GGT, Week 26
|
4.5 Units Per Liter
Standard Deviation 4.70
|
0.1 Units Per Liter
Standard Deviation 7.25
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples was collected for the assessment of clinical chemistry parameters including Albumin. and Total Protein. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Albumin, Week 1
|
-1.13 Grams per Liter
Standard Deviation 1.973
|
-1.62 Grams per Liter
Standard Deviation 1.266
|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Albumin, Week 4
|
-0.89 Grams per Liter
Standard Deviation 2.529
|
-0.83 Grams per Liter
Standard Deviation 1.641
|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Albumin, Week 8
|
-0.03 Grams per Liter
Standard Deviation 1.983
|
-0.57 Grams per Liter
Standard Deviation 2.434
|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Albumin, Week 12
|
-0.73 Grams per Liter
Standard Deviation 1.800
|
-0.56 Grams per Liter
Standard Deviation 1.965
|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Albumin, Week 24
|
-2.12 Grams per Liter
Standard Deviation 2.198
|
0.20 Grams per Liter
Standard Deviation 1.356
|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Albumin, Week 26
|
-1.59 Grams per Liter
Standard Deviation 2.366
|
-0.24 Grams per Liter
Standard Deviation 1.775
|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Total Protein, Week 1
|
-2.49 Grams per Liter
Standard Deviation 3.504
|
-2.02 Grams per Liter
Standard Deviation 2.147
|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Total Protein, Week 4
|
-3.61 Grams per Liter
Standard Deviation 4.100
|
-1.60 Grams per Liter
Standard Deviation 2.659
|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Total Protein, Week 8
|
-2.67 Grams per Liter
Standard Deviation 3.492
|
-1.80 Grams per Liter
Standard Deviation 3.629
|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Total Protein, Week 12
|
-2.44 Grams per Liter
Standard Deviation 2.274
|
-2.02 Grams per Liter
Standard Deviation 3.337
|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Total Protein, Week 24
|
-3.22 Grams per Liter
Standard Deviation 3.858
|
-1.71 Grams per Liter
Standard Deviation 2.461
|
|
Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein
Total Protein, Week 26
|
-2.38 Grams per Liter
Standard Deviation 3.379
|
-2.86 Grams per Liter
Standard Deviation 2.511
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C3, Week 1
|
0.836 Grams per Liter
Interval 0.745 to 0.939
|
0.899 Grams per Liter
Interval 0.798 to 1.012
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C3, Week 4
|
0.867 Grams per Liter
Interval 0.788 to 0.954
|
0.840 Grams per Liter
Interval 0.741 to 0.952
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C3, Week 8
|
0.888 Grams per Liter
Interval 0.796 to 0.99
|
0.896 Grams per Liter
Interval 0.765 to 1.051
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C3, Week 12
|
0.852 Grams per Liter
Interval 0.755 to 0.961
|
0.888 Grams per Liter
Interval 0.772 to 1.023
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C3, Week 24
|
0.845 Grams per Liter
Interval 0.754 to 0.948
|
0.912 Grams per Liter
Interval 0.782 to 1.064
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C3, Week 26
|
0.883 Grams per Liter
Interval 0.781 to 0.998
|
0.886 Grams per Liter
Interval 0.784 to 1.002
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C4, Baseline
|
0.211 Grams per Liter
Interval 0.175 to 0.254
|
0.197 Grams per Liter
Interval 0.175 to 0.223
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C4, Week 1
|
0.205 Grams per Liter
Interval 0.173 to 0.242
|
0.200 Grams per Liter
Interval 0.175 to 0.228
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C4, Week 4
|
0.202 Grams per Liter
Interval 0.17 to 0.241
|
0.183 Grams per Liter
Interval 0.156 to 0.214
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C4, Week 8
|
0.201 Grams per Liter
Interval 0.172 to 0.234
|
0.202 Grams per Liter
Interval 0.174 to 0.235
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C4, Week 12
|
0.194 Grams per Liter
Interval 0.163 to 0.231
|
0.213 Grams per Liter
Interval 0.172 to 0.263
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C4, Week 24
|
0.205 Grams per Liter
Interval 0.174 to 0.242
|
0.200 Grams per Liter
Interval 0.168 to 0.238
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C4, Week 26
|
0.219 Grams per Liter
Interval 0.184 to 0.261
|
0.205 Grams per Liter
Interval 0.178 to 0.235
|
|
Absolute Values of Complement C3 And C4 at Each Timepoint
Complement C3, Baseline
|
0.876 Grams per Liter
Interval 0.78 to 0.985
|
0.913 Grams per Liter
Interval 0.798 to 1.046
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C3, Week 1 Ratio to Baseline
|
0.954 Ratio
Interval 0.889 to 1.024
|
0.984 Ratio
Interval 0.915 to 1.059
|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C3, Week 4, Ratio to Baseline
|
0.989 Ratio
Interval 0.945 to 1.036
|
0.919 Ratio
Interval 0.83 to 1.019
|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C3, Week 12, Ratio to Baseline
|
0.972 Ratio
Interval 0.907 to 1.042
|
1.002 Ratio
Interval 0.913 to 1.1
|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C3, Week 8, Ratio to Baseline
|
1.013 Ratio
Interval 0.935 to 1.098
|
0.981 Ratio
Interval 0.865 to 1.114
|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C3, Week 24, Ratio to Baseline
|
0.965 Ratio
Interval 0.876 to 1.062
|
1.028 Ratio
Interval 0.976 to 1.084
|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C3, Week 26, Ratio to Baseline
|
1.008 Ratio
Interval 0.934 to 1.087
|
0.999 Ratio
Interval 0.92 to 1.085
|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C4, Week 1, Ratio to Baseline
|
0.972 Ratio
Interval 0.863 to 1.095
|
1.013 Ratio
Interval 0.895 to 1.146
|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C4, Week 4, Ratio to Baseline
|
0.959 Ratio
Interval 0.821 to 1.119
|
0.926 Ratio
Interval 0.813 to 1.056
|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C4, Week 8, Ratio to Baseline
|
0.952 Ratio
Interval 0.85 to 1.067
|
1.024 Ratio
Interval 0.858 to 1.222
|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C4, Week 12, Ratio to Baseline
|
0.919 Ratio
Interval 0.813 to 1.04
|
1.101 Ratio
Interval 0.972 to 1.246
|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C4, Week 24, Ratio to Baseline
|
0.973 Ratio
Interval 0.873 to 1.085
|
1.034 Ratio
Interval 0.952 to 1.122
|
|
Ratio to Baseline at Each Timepoint of Complement C3 And C4
Complement C4, Week 26, Ratio to Baseline
|
1.040 Ratio
Interval 0.925 to 1.168
|
1.060 Ratio
Interval 0.989 to 1.135
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 1 (2 hours), Day 1 (8 hours), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Systolic blood pressure (sBP) is a measure of blood pressure while the heart is beating. Diastolic blood pressure (dBP) is a measure of blood pressure while the heart is relaxed. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Day 1 (2 hours)
|
-4.48 Millimeters of mercury (mmHg)
Standard Deviation 6.933
|
0.34 Millimeters of mercury (mmHg)
Standard Deviation 6.963
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Day 1 (8 hours)
|
1.22 Millimeters of mercury (mmHg)
Standard Deviation 6.522
|
2.54 Millimeters of mercury (mmHg)
Standard Deviation 6.318
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Day 2
|
1.72 Millimeters of mercury (mmHg)
Standard Deviation 6.086
|
1.34 Millimeters of mercury (mmHg)
Standard Deviation 7.115
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Day 3
|
1.22 Millimeters of mercury (mmHg)
Standard Deviation 7.632
|
2.64 Millimeters of mercury (mmHg)
Standard Deviation 7.111
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Day 5
|
3.52 Millimeters of mercury (mmHg)
Standard Deviation 8.877
|
2.24 Millimeters of mercury (mmHg)
Standard Deviation 7.363
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Week 1
|
4.72 Millimeters of mercury (mmHg)
Standard Deviation 7.952
|
-1.36 Millimeters of mercury (mmHg)
Standard Deviation 6.679
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Week 2
|
1.92 Millimeters of mercury (mmHg)
Standard Deviation 5.797
|
0.74 Millimeters of mercury (mmHg)
Standard Deviation 3.063
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Week 4
|
0.02 Millimeters of mercury (mmHg)
Standard Deviation 6.091
|
-0.06 Millimeters of mercury (mmHg)
Standard Deviation 5.622
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Week 8
|
4.92 Millimeters of mercury (mmHg)
Standard Deviation 5.034
|
-0.66 Millimeters of mercury (mmHg)
Standard Deviation 6.173
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Week 12
|
-2.18 Millimeters of mercury (mmHg)
Standard Deviation 7.916
|
0.08 Millimeters of mercury (mmHg)
Standard Deviation 6.943
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Week 18
|
-1.18 Millimeters of mercury (mmHg)
Standard Deviation 10.532
|
0.52 Millimeters of mercury (mmHg)
Standard Deviation 6.905
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Week 24
|
-2.78 Millimeters of mercury (mmHg)
Standard Deviation 5.849
|
4.52 Millimeters of mercury (mmHg)
Standard Deviation 10.418
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
sBP, Week 26
|
-4.88 Millimeters of mercury (mmHg)
Standard Deviation 8.527
|
2.97 Millimeters of mercury (mmHg)
Standard Deviation 8.819
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Day 1 (2 hours)
|
1.30 Millimeters of mercury (mmHg)
Standard Deviation 7.002
|
-1.99 Millimeters of mercury (mmHg)
Standard Deviation 7.861
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Day 1 (8 hours)
|
1.90 Millimeters of mercury (mmHg)
Standard Deviation 5.045
|
0.11 Millimeters of mercury (mmHg)
Standard Deviation 5.180
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Day 2
|
1.40 Millimeters of mercury (mmHg)
Standard Deviation 3.960
|
-2.29 Millimeters of mercury (mmHg)
Standard Deviation 5.842
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Day 3
|
1.60 Millimeters of mercury (mmHg)
Standard Deviation 2.823
|
-3.09 Millimeters of mercury (mmHg)
Standard Deviation 6.931
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Day 5
|
3.10 Millimeters of mercury (mmHg)
Standard Deviation 6.056
|
-1.89 Millimeters of mercury (mmHg)
Standard Deviation 6.662
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Week 1
|
4.90 Millimeters of mercury (mmHg)
Standard Deviation 4.303
|
-3.39 Millimeters of mercury (mmHg)
Standard Deviation 6.107
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Week 2
|
5.20 Millimeters of mercury (mmHg)
Standard Deviation 4.454
|
-4.59 Millimeters of mercury (mmHg)
Standard Deviation 4.786
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Week 4
|
4.50 Millimeters of mercury (mmHg)
Standard Deviation 4.463
|
-2.59 Millimeters of mercury (mmHg)
Standard Deviation 5.633
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Week 8
|
4.20 Millimeters of mercury (mmHg)
Standard Deviation 6.244
|
-2.49 Millimeters of mercury (mmHg)
Standard Deviation 6.243
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Week 12
|
3.20 Millimeters of mercury (mmHg)
Standard Deviation 5.759
|
-1.96 Millimeters of mercury (mmHg)
Standard Deviation 6.028
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Week 18
|
4.10 Millimeters of mercury (mmHg)
Standard Deviation 4.078
|
-1.07 Millimeters of mercury (mmHg)
Standard Deviation 6.905
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Week 24
|
3.50 Millimeters of mercury (mmHg)
Standard Deviation 4.622
|
-1.73 Millimeters of mercury (mmHg)
Standard Deviation 6.803
|
|
Change From Baseline in Systolic and Diastolic Blood Pressure
dBP, Week 26
|
2.50 Millimeters of mercury (mmHg)
Standard Deviation 4.602
|
0.93 Millimeters of mercury (mmHg)
Standard Deviation 8.825
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 1 (2 hours), Day 1 (8 hours), Day 2, 3, 5, Week 1, 2, 4, 8, 12, 18, 24 and 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Body temperature was measured in participants in resting state. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Body Temperature
Week 2
|
0.01 Degrees Celsius
Standard Deviation 0.303
|
0.20 Degrees Celsius
Standard Deviation 0.380
|
|
Change From Baseline in Body Temperature
Week 4
|
-0.18 Degrees Celsius
Standard Deviation 0.336
|
-0.09 Degrees Celsius
Standard Deviation 0.335
|
|
Change From Baseline in Body Temperature
Day 3
|
-0.10 Degrees Celsius
Standard Deviation 0.353
|
0.11 Degrees Celsius
Standard Deviation 0.247
|
|
Change From Baseline in Body Temperature
Day 5
|
-0.05 Degrees Celsius
Standard Deviation 0.341
|
0.45 Degrees Celsius
Standard Deviation 0.381
|
|
Change From Baseline in Body Temperature
Week 1
|
-0.25 Degrees Celsius
Standard Deviation 0.360
|
0.16 Degrees Celsius
Standard Deviation 0.295
|
|
Change From Baseline in Body Temperature
Week 8
|
-0.14 Degrees Celsius
Standard Deviation 0.212
|
0.28 Degrees Celsius
Standard Deviation 0.286
|
|
Change From Baseline in Body Temperature
Week 12
|
-0.05 Degrees Celsius
Standard Deviation 0.331
|
0.29 Degrees Celsius
Standard Deviation 0.330
|
|
Change From Baseline in Body Temperature
Week 18
|
-0.04 Degrees Celsius
Standard Deviation 0.347
|
0.11 Degrees Celsius
Standard Deviation 0.314
|
|
Change From Baseline in Body Temperature
Week 24
|
0.01 Degrees Celsius
Standard Deviation 0.285
|
0.11 Degrees Celsius
Standard Deviation 0.440
|
|
Change From Baseline in Body Temperature
Week 26
|
0.20 Degrees Celsius
Standard Deviation 0.316
|
0.37 Degrees Celsius
Standard Deviation 0.421
|
|
Change From Baseline in Body Temperature
Day 1, 2 hours
|
0.07 Degrees Celsius
Standard Deviation 0.291
|
0.19 Degrees Celsius
Standard Deviation 0.328
|
|
Change From Baseline in Body Temperature
Day 1, 8 hours
|
0.21 Degrees Celsius
Standard Deviation 0.152
|
0.44 Degrees Celsius
Standard Deviation 0.284
|
|
Change From Baseline in Body Temperature
Day 2
|
-0.05 Degrees Celsius
Standard Deviation 0.259
|
0.12 Degrees Celsius
Standard Deviation 0.339
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 1 (2 hour), Day 1 (8 hour), Day 2, 3, 5, Week 1, 4, 8, 12, 18, 24 and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
The vital signs followed in this analysis was pulse rate, expressed as beats per minute (bpm). Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in Pulse Rate
Pulse Rate, Week 12
|
0.54 Beats per minute (BPM)
Standard Deviation 12.479
|
6.62 Beats per minute (BPM)
Standard Deviation 11.918
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Week 18
|
3.04 Beats per minute (BPM)
Standard Deviation 15.689
|
11.73 Beats per minute (BPM)
Standard Deviation 12.640
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Day 1, 2 hour
|
-5.96 Beats per minute (BPM)
Standard Deviation 5.529
|
2.13 Beats per minute (BPM)
Standard Deviation 6.755
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Day 1, 8 hour
|
-4.16 Beats per minute (BPM)
Standard Deviation 5.999
|
1.63 Beats per minute (BPM)
Standard Deviation 5.892
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Day 2
|
7.24 Beats per minute (BPM)
Standard Deviation 7.626
|
9.53 Beats per minute (BPM)
Standard Deviation 8.596
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Day 3
|
1.14 Beats per minute (BPM)
Standard Deviation 9.195
|
4.53 Beats per minute (BPM)
Standard Deviation 9.833
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Day 5
|
4.74 Beats per minute (BPM)
Standard Deviation 13.378
|
6.83 Beats per minute (BPM)
Standard Deviation 8.631
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Week 1
|
0.94 Beats per minute (BPM)
Standard Deviation 9.393
|
5.73 Beats per minute (BPM)
Standard Deviation 6.001
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Week 2
|
5.24 Beats per minute (BPM)
Standard Deviation 9.965
|
8.53 Beats per minute (BPM)
Standard Deviation 5.714
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Week 4
|
2.24 Beats per minute (BPM)
Standard Deviation 10.036
|
7.73 Beats per minute (BPM)
Standard Deviation 10.994
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Week 8
|
1.24 Beats per minute (BPM)
Standard Deviation 9.359
|
5.13 Beats per minute (BPM)
Standard Deviation 8.495
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Week 24
|
-0.06 Beats per minute (BPM)
Standard Deviation 13.603
|
14.73 Beats per minute (BPM)
Standard Deviation 9.943
|
|
Change From Baseline in Pulse Rate
Pulse Rate, Week 26
|
3.74 Beats per minute (BPM)
Standard Deviation 15.365
|
14.73 Beats per minute (BPM)
Standard Deviation 11.377
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 1 (2 hour), Day 1 (8 hour), Day 2, 3, 5, Week 1, 4, 8, 12, 18, 24 and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
12-lead ECG were performed in a supine position using an automated ECG machine that calculated the heart rate and measured PR interval, QRS duration, QT interval and corrected QT using Fridericia's Formula (QTc\[MB13.1\]F) intervals. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the aggregate \[MB14.1\]value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Day 1, 2 hour
|
-0.84 Milliseconds
Standard Deviation 4.344
|
-2.64 Milliseconds
Standard Deviation 12.942
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Day 1, 8 hour
|
-2.27 Milliseconds
Standard Deviation 3.900
|
-3.65 Milliseconds
Standard Deviation 11.480
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Day 2
|
4.53 Milliseconds
Standard Deviation 12.204
|
-0.46 Milliseconds
Standard Deviation 13.476
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Day 3
|
-0.20 Milliseconds
Standard Deviation 8.295
|
0.23 Milliseconds
Standard Deviation 9.007
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Day 5
|
1.33 Milliseconds
Standard Deviation 7.378
|
-3.38 Milliseconds
Standard Deviation 12.322
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Week 1
|
1.08 Milliseconds
Standard Deviation 8.925
|
-0.92 Milliseconds
Standard Deviation 11.653
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Week 2
|
4.04 Milliseconds
Standard Deviation 16.780
|
0.07 Milliseconds
Standard Deviation 9.145
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Week 4
|
5.45 Milliseconds
Standard Deviation 11.707
|
2.43 Milliseconds
Standard Deviation 12.669
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Week 8
|
3.46 Milliseconds
Standard Deviation 5.707
|
0.83 Milliseconds
Standard Deviation 11.991
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Week 12
|
2.53 Milliseconds
Standard Deviation 4.195
|
-1.60 Milliseconds
Standard Deviation 15.803
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Week 18
|
1.78 Milliseconds
Standard Deviation 3.036
|
-1.32 Milliseconds
Standard Deviation 11.759
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Week 24
|
2.13 Milliseconds
Standard Deviation 3.876
|
-0.36 Milliseconds
Standard Deviation 15.513
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
PR Interval, Aggregate, Week 26
|
4.40 Milliseconds
Standard Deviation 7.092
|
-2.89 Milliseconds
Standard Deviation 11.269
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Day 1, 2 hour
|
-1.63 Milliseconds
Standard Deviation 1.493
|
-0.82 Milliseconds
Standard Deviation 2.483
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Day 1, 8 hour
|
-0.48 Milliseconds
Standard Deviation 1.954
|
-1.26 Milliseconds
Standard Deviation 1.973
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Day 2
|
0.39 Milliseconds
Standard Deviation 2.023
|
0.00 Milliseconds
Standard Deviation 2.253
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Day 3
|
1.89 Milliseconds
Standard Deviation 2.821
|
0.41 Milliseconds
Standard Deviation 1.902
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Day 5
|
-0.36 Milliseconds
Standard Deviation 2.627
|
-0.34 Milliseconds
Standard Deviation 3.247
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Week 1
|
0.03 Milliseconds
Standard Deviation 1.737
|
-2.27 Milliseconds
Standard Deviation 2.295
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Week 2
|
0.26 Milliseconds
Standard Deviation 2.196
|
-0.93 Milliseconds
Standard Deviation 1.937
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Week 4
|
0.15 Milliseconds
Standard Deviation 3.106
|
-0.59 Milliseconds
Standard Deviation 1.954
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Week 8
|
1.19 Milliseconds
Standard Deviation 2.745
|
-0.80 Milliseconds
Standard Deviation 2.106
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Week 12
|
0.93 Milliseconds
Standard Deviation 3.296
|
-0.81 Milliseconds
Standard Deviation 2.597
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Week 18
|
1.40 Milliseconds
Standard Deviation 3.351
|
0.02 Milliseconds
Standard Deviation 3.145
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Week 24
|
0.46 Milliseconds
Standard Deviation 1.795
|
-2.14 Milliseconds
Standard Deviation 2.546
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QRS Duration, Aggregate, Week 26
|
-0.41 Milliseconds
Standard Deviation 3.316
|
-4.07 Milliseconds
Standard Deviation 2.887
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Day 1, 2 hour
|
-5.21 Milliseconds
Standard Deviation 5.651
|
-8.39 Milliseconds
Standard Deviation 17.499
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Day 1, 8 hour
|
-1.39 Milliseconds
Standard Deviation 8.188
|
-6.92 Milliseconds
Standard Deviation 16.608
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Day 2
|
-18.21 Milliseconds
Standard Deviation 8.801
|
-21.93 Milliseconds
Standard Deviation 9.133
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Day 3
|
-16.94 Milliseconds
Standard Deviation 14.136
|
-34.99 Milliseconds
Standard Deviation 18.932
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Day 5
|
-20.66 Milliseconds
Standard Deviation 16.160
|
-19.39 Milliseconds
Standard Deviation 15.006
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Week 1
|
-4.01 Milliseconds
Standard Deviation 12.293
|
-8.60 Milliseconds
Standard Deviation 16.612
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Week 2
|
-15.61 Milliseconds
Standard Deviation 17.242
|
-17.66 Milliseconds
Standard Deviation 12.158
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Week 4
|
-11.01 Milliseconds
Standard Deviation 14.937
|
-11.07 Milliseconds
Standard Deviation 21.302
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Week 8
|
-10.34 Milliseconds
Standard Deviation 14.871
|
-11.67 Milliseconds
Standard Deviation 13.038
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Week 12
|
-7.13 Milliseconds
Standard Deviation 18.140
|
-12.78 Milliseconds
Standard Deviation 18.728
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Week 18
|
-4.47 Milliseconds
Standard Deviation 22.321
|
-19.39 Milliseconds
Standard Deviation 20.395
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Week 24
|
-6.01 Milliseconds
Standard Deviation 26.007
|
-23.96 Milliseconds
Standard Deviation 16.773
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QT Interval, Aggregate, Week 26
|
-7.27 Milliseconds
Standard Deviation 22.688
|
-33.78 Milliseconds
Standard Deviation 17.359
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Day 1, 2 hour
|
-12.59 Milliseconds
Standard Deviation 3.511
|
-11.63 Milliseconds
Standard Deviation 16.082
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Day 1, 8 hour
|
-6.20 Milliseconds
Standard Deviation 6.892
|
-7.97 Milliseconds
Standard Deviation 7.896
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Day 2
|
-5.97 Milliseconds
Standard Deviation 6.321
|
-9.73 Milliseconds
Standard Deviation 7.506
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Day 3
|
-10.09 Milliseconds
Standard Deviation 6.675
|
-26.49 Milliseconds
Standard Deviation 9.100
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Day 5
|
-7.04 Milliseconds
Standard Deviation 8.360
|
-9.57 Milliseconds
Standard Deviation 8.345
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Week 1
|
-2.82 Milliseconds
Standard Deviation 6.837
|
-3.45 Milliseconds
Standard Deviation 10.648
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Week 2
|
-4.94 Milliseconds
Standard Deviation 6.690
|
-7.17 Milliseconds
Standard Deviation 10.401
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Week 4
|
-2.34 Milliseconds
Standard Deviation 5.754
|
-5.07 Milliseconds
Standard Deviation 10.253
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Week 8
|
-2.91 Milliseconds
Standard Deviation 7.425
|
-4.00 Milliseconds
Standard Deviation 9.108
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Week 12
|
-1.84 Milliseconds
Standard Deviation 4.347
|
-5.67 Milliseconds
Standard Deviation 10.444
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Week 18
|
4.98 Milliseconds
Standard Deviation 5.990
|
-2.93 Milliseconds
Standard Deviation 10.040
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Week 24
|
0.62 Milliseconds
Standard Deviation 8.127
|
-8.71 Milliseconds
Standard Deviation 6.705
|
|
Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate
QTcF Interval, Aggregate, Week 26
|
-1.71 Milliseconds
Standard Deviation 6.968
|
-11.20 Milliseconds
Standard Deviation 10.311
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose), Week 4, Week 12, and Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Serum samples were collected to determine the presence of anti-depemokimab binding antibodies using a validated bioanalytical method. Data is reported by visit. The results were categorized as negative and positive. A participant is considered positive if they have at least one positive post-Baseline ADA result. Number of participants with positive ADAs against depemokimab was reported in this outcome measure.
Outcome measures
| Measure |
Depemokimab 100mg
n=10 Participants
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 Participants
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Depemokimab
Day 1, Pre-dose
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Depemokimab
Week 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Depemokimab
Week 12
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Depemokimab
Week 26
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 26Population: The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. No participants had positive ADAs to depemokimab therefore, no data was collected for titers of ADAs.
Serum samples were collected to determine the presence of anti-depemokimab binding antibodies using a validated bioanalytical method. Data is reported by visit. Titer was only measured when a positive result was found.
Outcome measures
Outcome data not reported
Adverse Events
Depemokimab 100mg
Depemokimab 300mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Depemokimab 100mg
n=10 participants at risk
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
|
Depemokimab 300mg
n=10 participants at risk
Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
|
|---|---|---|
|
Investigations
Blood creatine phosphokinase increased
|
80.0%
8/10 • Number of events 11 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
40.0%
4/10 • Number of events 6 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Blood uric acid increased
|
30.0%
3/10 • Number of events 4 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
40.0%
4/10 • Number of events 4 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Albumin urine present
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
50.0%
5/10 • Number of events 9 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Red blood cells urine positive
|
10.0%
1/10 • Number of events 2 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
30.0%
3/10 • Number of events 4 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Protein urine present
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
30.0%
3/10 • Number of events 4 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Urinary casts present
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
30.0%
3/10 • Number of events 4 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Neutrophil count increased
|
20.0%
2/10 • Number of events 2 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Protein total decreased
|
20.0%
2/10 • Number of events 2 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 3 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Monocyte count increased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 3 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Heart rate increased
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 4 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Blood albumin decreased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Blood creatinine increased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
2/10 • Number of events 2 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Infections and infestations
Varicella
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Cardiac disorders
Sinus bradycardia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
|
Investigations
Blood glucose increased
|
0.00%
0/10 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER